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What is a Responsible Person (RP)?
Every license issued to a terminal distributor or drug distributor (hospital, pharmacy, wholesaler, clinic, manufacturer, EMS, lab, etc.) by the Ohio Board of Pharmacy requires there to be a responsible person (RP). The RP ensures the licensee is compliant with all applicable state and federal laws, regulations, and rules governing the distribution of dangerous drugs. This includes supervision and control of dangerous drugs, security and control of dangerous drugs, and maintaining all drug records otherwise required. Home Medical Equipment Service Providers have similar requirements for designated representatives.
A terminal distributor or drug distributor must have an RP at all times. When there is a change of RP, the Board must be notified within ten days of the effective date of the appointment of the new RP. This requires the submission of a Change of Responsible Person Request in eLicense Ohio and the payment of a $15.00 processing fee.
Responsible Person Site Visit Sample Checklist
The Board has created a Responsible Person Site Visit Sample Checklist, which is intended to assist TDDDs in complying with the responsible person requirements of 4729:5-2-01. To review the checklist, visit: www.pharmacy.ohio.gov/RPChecklist.
REMINDER: This rule requires a copy of this documentation to be maintained at, or accessible by, the TDDD where the visit was conducted for immediate on-site inspection by an agent, officer, or inspector of the Board.
Additional Guidance and Questions
For more information regarding these requirements, please review the Board’s guidance document at www.pharmacy.ohio.gov/RPGuide.
If you need additional information, the most expedient way to have your questions answered will be to e-mail the Board office by visiting: http://www.pharmacy.ohio.gov/contact.aspx.
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